Demystifying the Investigational New Drug (IND) Application for Drugs and Biologics (3of14) REdI '18

CDER’s Kevin Bugin provides a brief history of the regulations behind Investigational New Drug (IND) applications. He shares an introduction to INDs, including what the application is and role of the application in the regulation of clinical research for new drugs and biological products. Bugin shares when the application is needed, the different categories and types of applications, and policy on jurisdiction and bundling. Finally, the presentation will share information on the pre-IND consultation program.
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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